法规知识库 · EMA 集中审评
Naglazyme
galsulfase · EMEA/H/C/000640 · 已授权
获批上市许可
2006-01-23
欧委会决定日
2024-12-12
持有人 / 申请人
BioMarin International Limited
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A16AB
治疗领域：Mucopolysaccharidosis VI
药理分类：Other alimentary tract and metabolism products
修订号：20 · 最新影响 PI 的程序：IB/0097
适应症（原文）：Naglazyme is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine-4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1). As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease. A key issue is to treat young patients aged <5 years suffering from a severe form of the disease, even though patients <5 years were not included in the pivotal phase-3 study.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2024-12-12 · 欧委会决定
2006-01-23 · 获批上市许可
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
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Naglazyme : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-12-16
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Naglazyme : EPAR - Risk-management-plan summary
rmp-summary · 2022-04-26
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Naglazyme-H-C-PSUSA-00001515-201905 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-04-23 · EMA/219130/2020
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Naglazyme : EPAR - Summary for the public
overview · 2011-04-01
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Naglazyme : EPAR - Scientific Discussion
scientific-discussion · 2006-10-30
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Naglazyme : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-10-30
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。